Allopregnanolone for Traumatic Brain Injury

(ALLO Trial)

Overseen By Christine E Marx, MD MA

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: VA Office of Research and Development

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 1 day

132 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will determine if allopregnanolone (ALLO) improves depression and pain symptoms in patients who have a history of mild traumatic brain injury (TBI) \[primary endpoints\]. The investigators will also determine if ALLO improves functional outcome \[secondary endpoint\]. Participants in this study will receive an intravenous infusion of either ALLO or placebo. Behavioral assessments will be conducted during the infusion and at several time points post-infusion.

Research Team

Christine E Marx, MD MA

Principal Investigator

Durham VA Medical Center, Durham, NC

Eligibility Criteria

This trial is for U.S. Military veterans aged 21-62 who have had a mild traumatic brain injury since 2001 and suffer from moderate depression (HAM-D score of at least 14) and musculoskeletal pain (BPI rating of at least 4). Participants must not be planning to change psychiatric medications or treatments during the study.

Inclusion Criteria

You have symptoms of psychosis, like seeing or hearing things that aren't there.

I experience confusion or disorientation.

My other health conditions are under control with medication.

Exclusion Criteria

I haven't used benzodiazepines, barbiturates, or opioids in the last 2 weeks.

I haven't been hospitalized for a serious illness in the last month and can manage my health conditions at home.

I am not pregnant or breast-feeding.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an intravenous infusion of either ALLO or placebo, including a loading dose, 4-hour infusion, and taper

1 day

1 visit (in-person)

Post-Infusion Assessment

Behavioral assessments conducted during infusion, post-taper, and at 24 hours post-infusion

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness with behavioral assessments at 7 days and 14 days post-infusion

2 weeks

2 visits (in-person)

Treatment Details

Interventions

• Allopregnanolone
• Placebo

Trial Overview The trial tests whether allopregnanolone, given through an IV, can help with depression and pain in those with past mild TBI. It compares this treatment against a placebo. The main goal is to see if it improves mood and pain, with a secondary focus on overall function.

Participant Groups

Group I: Placebo Experimental Treatment 1 Intervention

ALLO 0 nM (placebo: loading dose, 4-hour infusion, taper)

Group II: ALLO 50 nM Experimental Treatment 1 Intervention

ALLO 50 nM (lower dose ALLO: loading dose, 4 hour infusion, taper)

Group III: ALLO 150 nM Experimental Treatment 1 Intervention

ALLO 150 nM (higher dose ALLO: loading dose, 4 hour infusion, taper)

Allopregnanolone is already approved in United States for the following indications:

Approved in United States as Zulresso for:

• Postpartum depression

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+